Catheters and Related Devices for Forming Passageways Between Blood Vessels or Other Anatomical Structures

ABSTRACT

The inventions described in this patent application include i) a torqueable introducer sheath which is useable in conjunction with a transvascular passageway forming catheter to effect precise rotational control of the catheter; ii) an anchorable guide catheter which is useable in conjunction with an intravascular imaging catheter and a transvascular passageway-forming catheter to effect precise positioning and aiming of the passageway-forming catheter; iii) a passageway forming catheter having a torqueable proximal portion to facilitate precise rotational positioning of the distal portion of the catheter; iv) a deflectable-tipped passageway forming catheter, v) various markers and other apparatus useable in conjunction with any of the passageway-forming catheters to facilitate precise positioning and aiming of the catheter, and vi) an apparatus which may be formed within a catheter to prevent a member, apparatus of flow of material from being inadvertently advanced through a lumen of the catheter.

RELATED APPLICATION

This patent application is a continuation-in-part of co-pending U.S.patent application Ser. No. 08/730,327 filed Oct. 11, 1996 and08/730,496 filed Oct. 11, 1996, the entire disclosures of which areexpressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to catheters, catheter positioning/aiming systems,and related methods for forming interstitial passageways (e.g.,interstitial tunnels) between two or more adjacently situated bloodvessels or other anatomical structures.

BACKGROUND OF THE INVENTION

Applicant has invented novel methods for bypassing obstructions inarteries and for performing other transvascular medical procedures,wherein a catheter device is inserted transluminally into the bloodvessel or other luminal anatomical structure and a tissue-penetratingelement (e.g., a puncturing member or a flow of energy) is passed out ofthe catheter, through the wall of the blood vessel or other anatomicalstructure in which the catheter is positioned, and into a second bloodvessel or other target anatomical structure. In this manner one or moreinterstitial passageways is/are formed from the blood vessel or otherluminal structure in which the catheter is positioned, to a second bloodvessel or other target tissue. These transvascular procedures, andcertain passageway forming catheters which are useable to perform theseprocedures, have previously been described in U.S. patent applicationSer. Nos. 08/730,327 entitled METHODS AND APPARATUS FOR BYPASSINGARTERIAL OBSTRUCTIONS AND/OR PERFORMING OTHER TRANSVASCULAR PROCEDURES,filed on Oct. 11, 1996 and 08/730,496 entitled, A DEVICE, SYSTEM ANDMETHOD FOR INTERSTITIAL TRANSVASCULAR INTERVENTION, filed Oct. 11, 1996.

In performing the above-summarized transvascular procedures, it isimportant that the passageway-forming catheter be properly positionedand oriented within the body in the order to ensure that thetissue-penetrating element will form the desired interstitialpassageway, at the desired location. If the catheter is improperlypositioned or improperly oriented, the resultant passageway(s) may failto perform their intended function (e.g., to channel blood from onelocation to another) or the tissue penetrating element of the cathetermay perforate or traumatize tissue(s) other than those intended to becanalized.

In many of the passageway-forming catheters devised by applicant, it isnecessary to precisely control the rotational orientation of thecatheter in order to accomplish the desired aiming of thetissue-penetrating element. However, when the passageway-formingcatheter is formed of relatively small diameter, thin-walled polymericmaterial capable of navigating small, tortuous blood vessels, thecatheter shaft may lack sufficient structural integrity to efficientlytransfer torque from the proximal end of the catheter to the distal endthereof. Such diminished torque transfer of the catheter shaft canprevent or interfere with the precise rotational orientation andpositioning of the distal portion of the catheter prior to formation ofthe extravascular passageway.

Additionally, to facilitate the use of any on-board imaging system(e.g., an intravascular ultrasound system inserted or built into thepassageway-forming catheter) or any separate intracorporeal orextracorporeal imaging services intended to assist in the precise aimingof the tissue-penetrating element, it is desirable for thetissue-penetrating catheter to be provided with appropriate markers orother indicia to enable the operator to utilize to discern the presentrotational orientation and position of the catheter and the projectedpath of the tissue-penetrating element.

Thus, there remains a need in the art for further development andmodification of applicant's previously described passageway-formingcatheter devices so as to provide for i) improved torque transfer to thedistal portion of the catheter and ii) precise rotational orientationand aiming of the catheter prior to deployment of the tissue penetratingelement.

SUMMARY OF THE INVENTION

The inventions described in this patent application include i) atorqueable introducer sheath which is useable in conjunction with atransvascular passageway forming catheter to effect precise rotationalcontrol of the catheter; ii) an anchorable guide catheter which isuseable in conjunction with an intravascular imaging catheter and atransvascular passageway-forming catheter to effect precise positioningand aiming of the passageway-forming catheter; iii) a passageway formingcatheter having a torqueable proximal portion to facilitate preciserotational positioning of the distal portion of the catheter; iv) adeflectable-tipped passageway forming catheter; v) various markers andother apparatus useable in conjunction with any of thepassageway-forming catheters to facilitate precise positioning andaiming of the catheter, and vi) an apparatus which may be formed withina catheter to prevent a member, apparatus of flow of material from beinginadvertently advanced through a lumen of the catheter.

Additional details and objects of each of the above-summarizedinventions will become apparent to those skilled in the art upon readingand understanding of the following detailed descriptions of preferredembodiments and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a torqueable sheath through which apassageway-forming catheter of the present invention may be inserted,and which may be used to facilitate subsequent rotational positioning ofthe distal portion of the passageway-forming catheter.

FIG. 1 a is a cut-away perspective view of the distal end of thetorqueable sheath of FIG. 1, and shown in phantom lines the preferredoperative positioning of a passageway-forming catheter within suchtorqueable sheath.

FIG. 1 b is a partial cut-away perspective view of portion 1 b of FIG.1, showing the braided wire layer formed within the proximal portion ofthe torqueable sheath.

FIG. 1 c is a cross-sectional view through line 1 c-1 c of FIG. 1.

FIG. 1 d is a cross-sectional view through line 1 d-1 d of FIG. 1.

FIG. 1 e is a cross-sectional view through line 1 e-1 e of FIG. 1.

FIG. 1 f is a perspective view of a typical passageway-forming catheterof Applicant's invention, as previously described in U.S. patentapplication Ser. No. 08/730,327, entitled METHODS AND APPARATUS FORBYPASSING ARTERIAL OBSTRUCTIONS AND/OR PERFORMING OTHER TRANSVASCULARPROCEDURES filed on Oct. 11, 1996.

FIG. 1 g is a cross-sectional view through line 1 g-1 g of FIG. 1 f, andadditional showing in phantom lines the preferred operative positioningof a torqueable sheath of the present invention relative to that portionof the passageway-forming catheter.

FIG. 2 is a perspective view of a guide catheter of the presentinvention having an anchoring balloon formed on the distal end thereof.

FIG. 2 a is a partial longitudinal sectional view through line 2 a-2 aof the guide catheter of FIG. 2, showing an intravascular ultrasounddevice operatively inserted into the guide catheter.

FIG. 2 b is a cross-sectional view through line 2 b-2 b of the guidecatheter FIG. 2 having an intravascular ultrasound catheter operativelyinserted therethrough.

FIG. 2 c is a cross-sectional view through line 2 c-2 c of FIG. 2 a.

FIG. 2 a′ is a partial longitudinal sectional view through line 2 a-2 aof the guide catheter of FIG. 2, showing a passageway-forming catheterof the present invention operatively inserted into the guide catheter.

FIG. 2 b′ is a cross sectional view through line 2 b-2 b of the guidecatheter of FIG. 2 having a passageway-forming catheter of the presentinvention operatively inserted therethrough.

FIG. 2 c′ is a cross-sectional view through line 2 c′-2 c′ of FIG. 2 a′.

FIG. 3 is a perspective view of the passageway forming catheter of thepresent invention which is useable in conjunction with the guidecatheter shown in FIGS. 2-2 c′.

FIG. 3 a is a perspective view of portion 3 a of FIG. 3.

FIG. 3 b is a longitudinal sectional view through line 3 b-3 b of FIG. 3a.

FIG. 3 c is a cross-sectional view through line 3 c-3 c of FIG. 3.

FIG. 3 d is a cross-sectional view through line 3 d-3 d of FIG. 3.

FIG. 4 a is a perspective view of a torqueable passageway-formingcatheter device of the present invention.

FIG. 4 b is a cross-sectional view through line 4 b-4 b of FIG. 4 a.

FIG. 4 c is a cross-sectional view through line 4 c-4 c of FIG. 4 a.

FIG. 4 d is a perspective view of the distal portion of apassageway-forming catheter of the present invention incorporating afirst marker thereon.

FIG. 4 e is a perspective view of the distal portion of a passagewayforming catheter of the present invention incorporating a second markerthereon.

FIG. 4 f is a perspective view of the distal portion of a passagewayforming catheter of the present invention incorporating a third markerthereon.

FIG. 4 g is a longitudinal sectional view of the distal portion of apassageway-forming catheter having a fourth marker of the presentinvention formed thereon.

FIG. 4 h is a longitudinal section view of the distal portion of apassageway forming catheter having a fifth marker formed thereon.

FIG. 4 h′ is a longitudinal sectional view of the passageway formingcatheter of FIG. 4 h wherein the marker has been advanced to itsoperative position by insertion of an IVUS catheter through one lumen ofthe passageway-forming catheter.

FIG. 4 i is a perspective view of the distal portion of a passagewayforming catheter having a sixth marker formed thereon.

FIG. 4 i′ is a perspective view of the distal portion of a passagewayforming catheter having a variation of the sixth marker of FIG. 4 iformed thereon.

FIG. 4 j is an elevational view of the distal portion of a passagewayforming catheter having a seventh marker formed thereon.

FIG. 4 j′ is an elevational view of the distal portion of the passagewaycatheter of FIG. 4 j wherein the seventh marker has been advanced to anoperative position by insertion of an IVUS catheter through one lumen ofthe passageway forming catheter.

FIG. 4 k is a longitudinal sectional view of the distal portion .of apassageway forming catheter wherein i) a reduced-diameter guidewirelumen has been formed to permit a guidewire to be temporarily advancedinto such guidewire lumen to act as a marker to facilitate preciserotational positioning of the catheter, and ii) an ultrasound chip hasbeen mounted on the catheter adjacent the outlet opening for the tissuepenetrating element so as to cause ultrasonic vibration and enhancedimageability of the tissue penetrating element when it is deployed outof the opening.

FIG. 4 l is an exploded perspective view of a modifiedpassageway-forming catheter, and a modified phased-array IVUS catheteruseable in conjunction therewith to effect precise rotationalpositioning of the passageway-forming catheter.

FIG. 4 l′ is a schematic diagram of one type of system which may beutilized to electronically mark or differentiate the image received froma single crystal on the phased array imaging catheter of FIG. 4 l.

FIG. 4 m is a perspective view of the distal portion of a passagewayforming catheter having an eighth marker formed thereon.

FIG. 4 m′ is an elevational view of the distal portion of a passagewayforming catheter having a variant of the eighth marker of FIG. 4 mformed thereon.

FIG. 5 is a longitudinal sectional view of an adjacent artery and vein,showing an energy-emitting/receiving guidance and positioning system ofthe present invention which is useable to effect precise positioning androtational orientation of the passageway-forming catheter.

FIG. 5 a is a partial longitudinal sectional view of apassageway-forming catheter of the present invention having analternative aiming/positioning system formed thereon, such systemcomprising an active (emitting) component and a passage (receiving)component.

FIG. 5 b is a partial longitudinal sectional view of anotherpassageway-forming catheter of the present invention which incorporatesanother aiming/positioning system thereon, such system comprising anactive (e.g., emitting) component mounted on the body of the catheterand an imaging catheter, component (e.g., an IVUS catheter) advanceablethrough an imaging catheter lumen of the passageway-forming catheter toimage the target tissue after the target tissue has been affected byenergy received from the active (emitting) component.

FIG. 5 c is a partial longitudinal sectional view of another passagewayforming catheter of the present invention having an alternativeaiming/positioning system wherein the tissue penetrating element of thecatheter is an elongate member having a sensor mounted thereon forsensing the location of the target tissue.

FIG. 5 d is a partial longitudinal sectional view of another passagewayforming catheter of the present invention (having an alternativeaiming/positioning system wherein an active (e.g., emitting) componentis mounted in specific relation to the outlet port for thetissue-penetrating element, and is adapted to emit a signal to animaging component (e.g., IVUS catheter) to accentuate the location ofthe outlet port and facilitate aiming of the catheter by use of theimaging device.

FIG. 5 e is a schematic diagram of one type of system which may beutilized to peak a signal received from the passive (e.g., receiving)component of an aiming/positioning system of FIGS. 5-5 c hereabove.

FIG. 6 is a schematic showing of the manner in which an extracorporealimaging apparatus is useable in conjunction with a marking scheme formedon a passageway-forming catheter of the present invention, to effectprecise positioning and rotational orientation of the passageway-formingcatheter.

FIG. 6 a is a showing of a first marking scheme useable with theextracorporeal imaging system of FIG. 6.

FIG. 6 b is a showing of a second marking scheme useable with theextracorporeal imaging system of FIG. 6.

FIG. 6 c is a showing of a third marking scheme useable with theextracorporeal imaging system of FIG. 6.

FIG. 7 is a perspective view of a deflectable-tipped. passageway formingcatheter system of the present invention which comprises a) adeflectable tipped catheter; b) an imaging component which isadvanceable through the deflectable-tipped catheter and c) atissue-penetrating component which is passable through thedeflectable-tipped catheter.

FIG. 7 a is a longitudinal sectional view of the handpiece portion ofthe deflectable tipped portion of FIG. 7.

FIG. 7 b is a longitudinal sectional view of the distal portion of thedeflectable-tipped catheter of FIG. 7.

FIG. 8 is a longitudinal sectional view of another passageway-formingcatheter which incorporates apparatus for preventing deployment of thetissue-penetrating element.

FIG. 8′ is a longitudinal sectional view of another passageway-formingcatheter which incorporates apparatus for preventing deployment of thetissue-penetrating element and for stabilizing the catheter within aluminal anatomical structure, wherein such apparatus is in an initialconfiguration whereby the lumen is blocked and the catheter isunstabilized.

FIG. 8″ is a longitudinal sectional view of another passageway-formingcatheter which incorporates apparatus for preventing deployment of thetissue-penetrating element and for stabilizing the catheter within aluminal anatomical structure, wherein such apparatus is in an operativeconfiguration wherein the lumen is open and the catheter is stabilized.

DETAILED DESCRIPTIONS PREFERRED EMBODIMENTS

The following detailed description and the accompanying drawings areprovided for the purpose of describing and illustrating presentlypreferred embodiments of the invention only, and are not intended tolimit the scope of the invention in any way.

It is to be appreciated that the individual elements and components ofeach of the embodiments described herebelow may be individually orcollectively incorporated into each of the other embodiments capable ofreceiving or incorporating such element(s) or component(s), and noeffort has been made to exhaustively describe all possible permutationsand combinations of the inventive elements and components describedherein.

-   i. Torqueable Introducer Sheath

Referring specifically to FIGS. 1-1 g, the present invention includes atorqueable introducer sheath 10 comprising an elongate pliable tubularsheath body 12 having a proximal end PE and a distal end DE. The tubularsheath body 12 comprises a proximal segment 14, a medial segment 16 anda distal segment 18. A hollow lumen 20 extends longitudinally throughthe tubular sheath body 12, such hollow lumen 20 being defined by aninner luminal surface 22. A proximal hand piece or connector assembly 24may be mounted on the proximal end PE of the sheath body 12 tofacilitate manipulation of the proximal end PE of the sheath body 12 andto receive and register against the hand piece 26 of any catheter whichis inserted through the torqueable introducer sheath 10.

A tubular catheter engaging member 28 is formed or mounted within thelumen 20 of the distal segment 18 of the tubular sheath body 12. Suchtubular catheter engaging member 28 has a lumen 30 which extendslongitudinally therethrough. The lumen 30 may be of any non-cylindricalor nonuniform configuration, such as “pair shape” or “egg-shape,”whereby the luminal surface or a portion thereof will engage and preventrotation of the catheter inserted through the sheath. An example of agenerally oval shaped lumen is shown in FIG. 1 a.

A plurality of elongate reinforcement members 32, formed of wire, fibersor other suitable material, are disposed within the proximal and medialsegments 14, 16 of the tubular sheath body 12. These reinforcementmembers 32 may be helically wound about the lumen 20 of the sheath body12 to form an overlapping braid structure 34. Other structures, such asa coil structure, may also be used. In particular, such overlappingbraid structure 34 may comprise two groups of individual elongatemembers 32 helically wound in opposite phase about the longitudinal axisLA of the tubular introducer sheath body 12, and at cross over points ofsuch groups of elongate members 32, the individual elongate members 32of one group will be alternately passed over and under the individualelongate members 32 of the other group, so as to provide a braidstructure 34 which will impart enhanced structural integrity and torquetransfer to the proximal 14 and medial 16 segments of the tubular sheathbody 12. In some embodiments, the distal segment 18 may also be providedwith the elongate members 32 and/or braided structure.

In embodiment of this sheath intended for coronary application, theindividual elongate members 32 may preferably be formed of stainlesssteel of 0.001-0.005 inch diameter. Each group of elongate members 32may consist of eight such stainless steel wire members in substantiallyparallel side-by-side relation to one another. The first and secondgroups of elongate members 32 will be helically wound about a tubularinner liner 36, in opposite phase such that the first and second groupsof elongate members will repeatedly cross over each other. At locationswhereat the groups of elongate members 32 cross over each other, eachindividual elongate member 32 of each group may be alternately threadedover and under the individual elongate members 32 of the other group, soas to provide an interwoven, braided structure 34 which will impartenhanced torqueability to the tubular sheath body 12. A tubular outerskin 15 is then formed over the wire braid structure 34 such that thewire braid structure 34 is captured or located between the tubular outerskin 15 and the tubular core member 36, as shown.

In at least some applications it may desirable to impart regionalizeddifferences in rigidity or hardness to the proximal and medial segments14, 16 of the tubular sheath body 12. In this manner, the outer skin 15of the proximal portion 14 may be formed of material which is more rigidor greater in hardness than that of the outer skin 15 of the medialportion 16. For example, the outer skin 15 of the proximal portion 14may be formed of thermoplastic, elastin (e.g., Pebax, polyurethane,silicone, polyester) or thermoset elastomer (e.g., polyurethane orflexibly epoxy) (e.g., Pebax) having a Shore D hardness of 60-72 whilethe outer skin 15 of the medial portion 16 may be formed of polymericmaterial (e.g., pebax) having a lesser hardness, such as a 40-60 Shore Dhardness on the shore D scale. The outer skin 15 of the distal portion18 may preferably have a Shore D hardness in the range of 30-40. Therelative lengths and hardness of the inner liner 36 and outer skin 15may be varied to adjust the overall stiffness of the catheter and thelocations of the transition areas between the proximal 14, medial 16 anddistal 18 segments of the sheath 10.

In the preferred embodiment, shown in the drawings, the inner liner isformed of polytetrafluoroethylene (PTFE) of consistent hardness from theproximal end PE to the distal end DE of the tubular sheath body 12.

With reference to FIGS. 1 f-1 g, one type of passageway-forming catheter40 which is useable in conjunction with the torqueable sheath 10comprises an elongate pliable catheter 40 having an irregular crosssectional configuration defining an upper portion 42 through which atissue-penetrating element 46 may pass and a lower portion 44 throughwhich an imaging catheter (e.g., an IVUS catheter) may pass.

A tissue-penetrating element 46 of the type previously described in U.S.patent application Ser. No. 08/730,327 is advanceable out of the distalend DE of the upper catheter portion. 42 such that the tissuepenetrating element 46 will diverge laterally from the longitudinal axisLA of the catheter device 40. In this manner, the tissue-penetratingelement 46 will pass through the wall of a blood vessel wherein thedistal portion of the catheter device 40 is positioned so as to createan extravascular passageway extending from the blood vessel to anotherblood vessel or other extravascular target location.

As shown in FIG. 1 g, when the catheter 40 is advanced through thetorqueable introducer sheath 10, the upper portion 42 of the catheterbody will engage the smaller diameter side of the lumen 30 of thecatheter engagement member 28, while the relatively large diameter lowercatheter portion 44 will engage the opposite end of such lumen 30, andthe passageway-forming catheter 40 will be thereby prevented by thecatheter engaging insert 28 from rotatably moving relative to thetubular body 12 of the sheath 10. In this manner, the operator maymanually grasp the proximal connector 24 and may apply rotational forceto the proximal connector 24, such that the rotational force. will betransmitted through the tubular sheath body 12 so as to cause the distalsegment 18 of the tubular sheath body 12 to rotate in a substantiallyone to one (1:1) relation to the proximal connector 24. In this manner,the torqueable introducer sheath 10 will cause the catheter 40 which hasbeen inserted through the sheath 10 to rotate in conjunction with thesheath 10, irrespective of whether the body of the catheter 40 hassufficient structural integrity to be capable of transmitting torquefrom its proximal end to its distal end. This construction allows theuse of a passageway-forming catheter 40 which is of relatively smalldiameter and formed of pliable or subtle material, while the torqueablesheath 10 may be of stronger and less pliable material capable oftransmitting torque and acting as guide for insertion of the catheter40. Additionally, the catheter engaging insert 28 may be positioned ator near the distal end of the sheath 10 so as to transmit torque to thecatheter 40 at a location at or near its distal tip, thereby eliminatingtorque or rotational stress on the majority of the catheter shaft andeliminating the potential for kinking or buckling of the small diameter,pliable catheter body. In this manner, the use of the sheath 10 of thepresent invention in conjunction with the catheter 40 provides for themaintenance of precise rotational control of the distal portion of thecatheter 40.

-   ii. Anchorable Guide Catheter

Referring to FIGS. 2-2 b′ there is provided an anchorable guide catheterwhich is useable in conjunction with i) an imaging catheter such as acommercially available IVUS catheter (e.g., 29 French Ultra-Crossavailable from Boston Scientific, 27 Orleans Dr., Sunnyvale, Calif.) andii) a transvascular passageway forming catheter, one example of which isshown in FIGS. 3 a-3 d of this application and other examples of whichare described in U.S. patent applications Ser. Nos. 08/730,327 and08/730,496.

The anchorable guide catheter 50, comprises a pliable tubular catheterbody 52 having a proximal end PE and a distal end DE. First and secondlumens 54, 56 extend longitudinally through the catheter body 52. Anopening 58 is formed in one side of the catheter body 52, so as toprovide an opening into the first lumen 54. A pressure exertive membersuch as a balloon 59 or other projectable apparatus such as a moveablefoot, is mounted on the catheter body 52 at a location laterallyopposite the location of the opening 58. An inflation fluid aperture 60is formed in the sidewall of the catheter body 52 between the balloon 58and the second lumen 56 such that balloon inflation fluid may pass intoand out of the balloon 59, through the second lumen 56.

A proximal connector assembly 62 is mounted on the proximal end PE ofthe catheter body 52. Such proximal connector assembly 62 has a side armport 64 in communication with the second lumen 56 such that ballooninflation fluid may be injected or withdrawn through the side arm port64 to cause alternate inflation and deflation of the balloon 59. Also,the proximal connector assembly 62 has a proximal port 66 through whichany elongate member of suitable size and configuration, such as theimaging (IVUS) catheter, a passageway forming catheter 40, or othercatheters equipped for introducing channel connectors, channel sizers,lumen blockers, etc. as described in Applicant's earlier-filed U.S.patent application Ser. Nos. 08/730,327 and 08/730,496, may be advancedthrough the first lumen 54 of the catheter body 52. The first lumen 54of the catheter body 52 may be of a shape or configuration which isanalogous to one or both of the catheters which are to be insertedthrough the first lumen 54 such that when such IVUS catheter, passagewayforming catheter 70 or other elongate member 15 inserted into the firstlumen 54, the outer surface(s) thereof will engage the inner surface ofthe first lumen 54 such that the IVUS catheter, passageway formingcatheter 70 or other elongate member will be prevented from rotatablymoving relative to the body of the catheter 52, and the operator willthereby maintain precise control over the rotational orientation ofthese apparatus. In particular, as shown in FIGS. 2 b-2 c, the firstlumen 54 may have an inner lumenal surface 64 of a “D” shape.

Referring to FIGS. 3 a-3 d, a particular passageway forming catheter 70which is useable in conjunction with the anchorable guide catheter 50may comprise a pliable catheter body 72 having at least a distal portion74 having a generally D-shaped outer surface 76 which is ofsubstantially the same size and configuration as the D-shaped luminalsurface 64 of the first lumen 54. A tissue penetrating element 78extends through the pliable catheter body 72 and is connected to atrigger 80 formed on the proximal hand piece 82 of the catheter device70 such that, when the trigger 80 is actuated, the tissue penetratingelement 78 will pass out of a side opening 80 formed in the D-shapedportion of the catheter body 72 such that the tissue penetrating element78 will diverge laterally from the longitudinal axis LA of the catheterbody 72, in this manner, the tissue penetrating element 78 may beutilized to form an extravascular passageway which extends through thewall of the blood vessel into which the catheter 70 is inserted, toanother blood vessel or other target location within the body.

Referring back to FIGS. 2 a-2 c′, the anchorable guide catheter 50 isinitially inserted into the vasculature and advanced to a position wherethe distal end DE of the balloon catheter body 52 and side opening 58are located adjacent the location at which it is desired to form anextravascular passageway. An imaging catheter 80, such as an IVUScatheter, is inserted through the proximal port 66, and is advancedthrough the first lumen 54 until the imaging catheter 80 is in aposition relative to the side opening 58 of the catheter body 52 toprovide an image of anatomical structures located in alignment with suchside opening 58. Thereafter, the guide catheter body 52 may be manuallyrotated until the image received through the imaging catheter 58indicates that the opening 58 is directly aligned with the location atwhich the extravascular passageway is to be formed. In this regard, thecatheter body 52 is of a torqueable construction, and may have the samedual-layer braided construction as described hereabove with respect tothe torqueable sheath 10. In this manner, the anchorable guide catheter50 may be manually rotated by the operator to effect precise rotationalpositioning of the opening 58 of the balloon anchorable guide catheterwithin the vasculature or other luminal anatomical structure withinwhich the guide catheter 50 is inserted.

After the opening 58 of the balloon anchorable guide catheter 50 hasbeen precisely rotationally positioned so that a passageway formingcatheter 70 subsequently inserted through the guide catheter 50 will beappropriately aimed at the target anatomical location, the balloon 59 ofthe guide catheter 50 will be inflated (or the other pressure exertivemember will be actuated) to engage the surrounding luminal anatomicalwall and to hold the distal portion of the guide catheter 50 insubstantially fixed longitudinal and rotational position/orientation. Inthis regard, the material in which the balloon 59 is formed may befrictionally textured or coated with adhesive or otherwise modified witha friction producing outer surface to enhance its friction against theluminal wall. In this manner the balloon 59 will soundly engage thesurrounding luminal wall to hold the distal portion of the guidecatheter 50 in fixed position.

Thereafter, the imaging catheter 80 will be extracted from the firstlumen 54, and a passageway-forming catheter such as that shown in FIGS.3 a-3 d and described hereabove, will then be inserted through the lumen54. The passageway forming catheter 70 may be advanced until the distalend DE of the passageway forming catheter body 72 abuts against thedistal end surface 82 of the first lumen 54 of the guide catheter 50.When so inserted, the D-shaped outer surface 76 of the distal portion 74of the passageway forming catheter body 72 will be in abutment with theD-shaped luminal surface 64 of the first lumen 54 of the guide catheterbody 52, as shown in FIG. 2 c′. In instances where the proximal portion(i.e., that portion proximal to the distal portion 74) of the passagewayforming catheter body 72 is not of the same D-shaped configuration, suchproximal portion may simply reside within the D-shaped first lumen 54 inthe manner shown in FIG. 2 b. Thus, it is not necessary that the entirelength of the passageway-forming catheter body 72 have the D-shapedouter surface 76, but only that a distal portion thereof have theD-shaped outer surface 76 so as to frictionally engage the D-shapedluminal surface 64 of the first lumen 54 in the manner shown.

Because the anchoring balloon 59 has been inflated, the guide catheterbody 52 will be prevented from rotating within the vasculature and willbe held in a substantially fixed rotational orientation such that theside opening 58 is in direct alignment with the other blood vessel ortarget location to which the extravascular passageway is to extend.Thus, after the passageway-forming catheter 70 has been inserted intothe first lumen 54 in the above-described manner, the triggering member80 may be actuated to cause the tissue penetrating element 78 to passout of the passageway forming catheter body 72, through the side opening58 of the guide catheter, through the wall of the blood vessel in whichthe guide catheter 50 is located, and into another blood vessel or otherextravascular target location. In some embodiments, the tissuepenetrating element 78 may comprise a tubular member having a guidewirelumen 81 extending longitudinally therethrough. When such guidewirelumen 81 is present, a guidewire 79 may optionally be advanced throughthe tissue penetrating element 78 and into the other blood vessel orextravascular target location, after the tissue-penetrating element 78has been advanced thereinto. After such guidewire 79 has been advancedinto the other blood vessel or extravascular target location, the tissuepenetrating element 78 may be retracted into the body of the passagewayforming catheter 70, and the passageway forming catheter 70 and balloonanchorable guide catheter 50 may be extracted from the body, leaving theguidewire 79 in place to guide other devices or operative instrumentsthrough the newly created extravascular passageway.

-   iii. Passageway-Forming Catheter Device Having Torqueable Proximal    Portion

FIGS. 4 a-4 e show another passageway-forming catheter device 100 of thepresent invention, which generally comprises an elongate catheter body102 with definable proximal 104, medial 106 and distal 108 segments ofvarying flexibility and torque strength.

The proximal segment 104 and medial segment 106 of the catheter body 102incorporate reinforcement members, such as a reinforcement member braid110, which will impart structural integrity to the proximal segment 104and medial segment 106, and will enhance the ability of the proximalsegment 104 and medial segment 106 to transmit torque from the proximalend of the catheter body 102. In some embodiments, the distal segment108 may also incorporate such reinforcement members and/or braid 110.The reinforcement members and braid may be similar to or the same asthat described in detail hereabove in reference to FIG. 1.

As shown in FIG. 4 a, the proximal segment 104 may be of greaterdiameter than the medial segment 106. In this manner, the proximalsegment 104 may comprise a cylindrical, dual lumen core member 140 a ofa first diameter D₁ about which the reinforcement members or wire braid110 are wrapped. An outer jacket 142 a is then formed about thereinforcement members or wire braid 110, as shown in FIG. 4 b.

The mid-portion 106 comprises a cylindrical core member 140 b ofdiameter D₂, about which the reinforcement members or wire braid 110 arewrapped. A cylindrical outer jacket 142 b is also formed about themid-portion 106 of the catheter body 102, and is continuous with theouter surface of the distal portion 108, as shown in FIG. 4 a.

It would be appreciated that the individual portions or members whichmake up each segment of 104, 106, 108 of the catheter body 102 may beformed of materials which have different physical properties (e.g.,hardness, flexural properties, etc.) so as to bring about the desiredregionalized variations in pliability and torque strength the catheterbody 102. For example, in a presently preferred embodiment, thecylindrical core member 140 a of the proximal portion 104 is formed of apolymer material of a first hardness (e.g., Pebax of 63E Shore Hardness)and the cylindrical core member 140 b of the mid-portion 106 is formedof a polymer material having a different hardness (e.g., Pebax of 40DShore Hardness). The outer jacket 142 a of the proximal portion 104 isformed of another polymeric material having yet a different hardness(e.g., Pebax 70D Shore Hardness) and the outer jacket 142 d of themid-portion 106 is formed of polymeric material having the same orsimilar hardness of that of the mid-portion 106 (e.g., Pebax of 40DShore Hardness) other polymeric materials which may be used to formportions or members of the catheter body 102 include nylon,polyurethane, polyester, polyvinyl chloride (PVC) etc.

The catheter body 102 has a bottom portion BP and an upper portion UP. Acurved or slanted frontal surface is formed on the distal end of theupper portion UP.

A first lumen 130 extends longitudinally through the catheter body fromthe proximal end to the distal end of the upper portion of the catheterbody, and terminates distally at the distal outlet aperture 134.

A second lumen 132 also extends longitudinally through the catheter bodyfrom the proximal end thereof to a closed end wall or plug at the distalend of the lower portion LP of the catheter body 102. A proximalconnector 136 is mounted on the proximal end of the catheter body. Aproximal connector 136 has a proximal end port 134 and a side arm port138. The proximal end port 134 is in communication with the first lumen130 of the catheter body 102, and the side arm port 138 is incommunication with the second lumen 132 of the catheter body 102. Atissue-penetrating element 150 extends through the first lumen 130. Thistissue penetrating element 150 may be any suitable type of tissuepenetrating element member, device, or flow of energy, as previouslydescribed in U.S. patent application Ser. No. 08/730,324, of which thisapplication is a continuation-in-part. In embodiments wherein the tissuepenetrating element 150 is an advanceable member or device, a handpieceof the type shown in FIG. 3 a-3 b may be mounted on the proximal endport 134 such that the trigger 80 is connected to the tissue penetratingelement 150 and is useable to alternately advance and retract the tissuepenetrating element 150, out of/into the outlet aperture 134.

An imaging catheter, such as an intravascular ultrasound (IVUS) cathetermay be inserted through one of the ports 134, 138 of the proximalconnector 136 connected to the second lumen 132. In this manner theimaging catheter (IVUS) may be advanced through the second lumen 132such that a distal portion of the imaging catheter extends into or outof and beyond the distal extent of the second lumen 132, thereby placingthe imaging transducer or image receiving apparatus at a vantage pointwhich is distal to the outlet aperture 134. Such imaging catheter maythen be utilized to image anatomical structures which are situatedadjacent to in the vicinity of the outlet aperture 134, and to view thepassage of the tissue-penetrating element 150 out of the outlet aperture134 and through/into the adjacent anatomical structure.

-   iv. A Deflectable Catheter System for Forming Extraluminal    Passageways

FIGS. 7-7 b show another type of catheter system which may be utilizedto form interstitial passageways between a luminal anatomical structure(e.g., a blood vessel) within which the catheter is positioned andanother target anatomical location (e.g., another blood vessel, chamberof the heart, organ, tumor, etc.).

As shown in FIG. 7, the system 1000 comprises a deflectable tippedcatheter 110 which is useable in combination with an imaging catheter112 (e.g., an IVUS catheter) and a tissue penetrating element 114 (e.g.,a sharp-tipped elongate member, or a flow of tissue-penetrating energy).

The deflectable tip catheter 110 comprises an elongate pliable catheterbody 1016 having a deflectable distal end DE and a proximal end PE whichis connected to a handpiece 1018.

A presently preferred construction of the handpiece 1118 is shown inFIG. 7 a, and a presently preferred construction of the distal end DE ofthe catheter body 1016 is shown in FIG. 7 b.

A working lumen 1020 extends longitudinally through the catheter body1016 and through an opening 1022 in the distal end DE of the catheterbody 1016. A secondary lumen 1026 extends longitudinally through thecatheter body 1016, at an off center location along one side of thecatheter body. Such secondary lumen 1026 terminates within the catheterbody near the distal end thereof, and is thus a blind lumen. A pull wire1024 extends longitudinally through the secondary lumen 1026 and thedistal end 1028 of the pull wire 1024 is anchored or attached to thecatheter body at a location within the catheter body, near the distalend thereof. The pull wire 1024 is axially moveable within the secondarylumen 1026 such that, when the pull wire 1024 is retracted in theproximal direction, it will cause the distal end DE of the catheter body1016 to deflect in lateral direction, toward the side on which thesecondary lumen 1026 is formed, as shown in FIG. 7 b.

The handpiece 1018 comprises a rear body portion 1030 and a forward bodyportion 1032 a knob 1034 is formed on the forward body portion 1032. Theproximal end of the forward body portion 1032 is received within aninner bore 1036 of the rear body portion 1030 and is slidablyretractable and advanceable within such bore 1036. A tubular member 1038is positioned axially within the bore 136 of the rear body portion 1030and extends through a portion of the forward body portion 132 as shown.This tube member 1038 is attached and anchored within the handpiece 1018by way of a nut 1039. The catheter body 1016 extends through the tubularmember 1038 and the proximal end PE of the catheter body 1016 isanchored within the rear body portion 1030, as shown. A slot 1040 isformed in the side of the tube member 1038. The pull wire 1014 extendsthrough a small hole formed in the side of the catheter body 1016 withinthe forward body portion 1032 and through the slot 1040. The proximalend of the pull wire 1024 is attached to a set screw 1042 mounted in theside of the forward body portion 1032. An O-ring 1046 is mounted withinan annular groove formed in the proximal portion of the forward bodyportion 1032 such that the O-ring will ride against the inner surface ofthe bore 1036 of the rear body portion 130 as the forward body portion1032 is advanced and retracted therewithin.

In operation, when it is desired to cause the distal end DE of thecatheter body 1016 to deflect laterally, the operator will grasp theknob 1034 of the forward body portion 1032 and will proximally retractthe forward body portion 1032 into the bore 1036 of the rear bodyportion 1030, while the catheter body 1016 remains axially stationarydue to its affixation to the proximal body portion 1030. In this manner,the pull wire 1024 will be proximally retracted within the secondarylumen 1026 and will cause the distal end DE of the catheter body 1016 todeflect in the desired lateral direction, as shown. Such deflection ofthe distal end DE of the catheter body 1016 may be utilized to cause thedistal end outlet aperture 1022 to be specifically directed or aimed atthe luminal wall of a luminal anatomical structure within which thecatheter body 1016 is inserted.

A first frusto conical bore 1050 is formed within an insert member 1052located in the rear body portion 1030, and within which the proximal endPE of the catheter body 116 is extended. This frusto conical bore 1050leads directly into the proximal end of the working lumen 1020 of thecatheter body 1016 and will facilitate distally directed advancement ofa guidewire, imaging catheter 1012, tissue penetrating element 1014, orother elongate apparatus through the main lumen 1020 of the catheterbody 1016.

Another insert member 1054 having an opposite redirected frusto conicalbore 1056 is also mounted within the bore 1036 of the rear body portion1030, proximal to the first insert member 1052. This oppositely directedfrusto conical bore 1056 will serve to guide and center the proximal endof a guidewire or similar elongate apparatus over which the catheterbody 116 may be advanced such that it passes out of the proximal end PEof the catheter body 116.

Optionally, a hemostasis valve and/or gripping apparatus 1060 may bemounted on the proximal end of the rear body portion 130, immediatelyadjacent the proximal end opening 1062 of the bore 136 through which theguidewire(s), imaging catheter 1012, tissue penetrating element 1014 orother elongate apparatus may be passed.

In a preferred mode of operation, the catheter body 1016 is initiallyinserted into a luminal anatomical structure such that the distal end DEof the catheter body 1016 is located generally adjacent a site at whichan interstitial passageway is to be formed through the wall of theluminal anatomical structure within which the catheter body 1016 ispositioned. The imaging catheter 1012 (e.g., an IVUS catheter) isadvanced through the proximal opening 1062, through the frusto conicalbore 1050, and through the working lumen 1020 of the catheter body 1016until the transducer or image-receiving element of the imaging catheter1012 is appropriately positioned to image the⁻side wall of the luminalanatomical structure within which the catheter body 1016 is insertedand/or the target anatomical location to which the interstitialpassageway is desired to extend. In many instanced, this will requirethat a distal portion of the imaging catheter 1012 protrudes slightlyout of and beyond the distal end opening 1022 of the working lumen 1020.With the image catheter 1012 in its operative position, it may beutilized to precisely locate the distal end DE of the catheter body 1016in the desired longitudinal location and rotational orientation whichwill cause the distal end opening 1022 to be in alignment with thespecific site on the wall of the luminal anatomical structure throughwhich the passageway is to be formed. In this manner, one or moreimageable markers or other aiming/positioning systems as described inthis patent application or in applicant's related patent applicationsmay be incorporated into the system 1000 to facilitate precise aimingand positioning of the distal end DE of the catheter body 1016.

After the distal end DE of the catheter body 1016 has beenlongitudinally and rotationally positioned/oriented, the imagingcatheter 1012 will be extracted and removed, and the tissue-penetratingelement 1014 will then be advanced through the proximal opening 1062,through the frusto conical bore 1050, and through the working lumen 1020until the tissue-penetrating element is near the distal end opening 1022but still contained within the working lumen 1020. Thereafter, theoperator will grasp the knob 1034 of the handpiece 1018 and will retractthe forward body portion 1032 of the handpiece rearwardly, into the rearbody portion 1030. This will cause the pull wire 1024 to retract andwill cause the distal end DE of the catheter to become laterallydeflected such that the distal end opening 1022 is positioned in directalignment with the site on the wall of the luminal anatomical structurethrough which the passageway is to be formed. Thereafter, thetissue-penetrating element 1014 will be further advanced out of thedistal end opening 1022 of the catheter body 1016, through the wall ofthe luminal anatomical structure, and through any intervening tissue,until the tissue-penetrating element 1012 emerges into the intendedtarget anatomical location.

Thereafter, the tissue-penetrating element 1014 maybe retracted throughthe working lumen 1020 and removed.

Thereafter, one or more secondary apparatus (e.g., channel connectordelivery catheters, channel enlarging/modifying catheters, blockercatheters, etc.), may be advanced through the working lumen 1020 of thecatheter to perform any desired modifications of the interstitialpassageway or delivery of ancillary devices to facilitate flow of bloodor biological fluids through the passageway, as desired.

Thereafter, when the procedure has been completed, the operator mayagain grasp the knob 1034 of the forward body portion 1032 and maydistally advance the forward body portion to its original position,thereby allowing the distal end DE of the catheter body 1016 to returnto its substantially straight, non-deflected configuration.

Those skilled in the art will appreciate that various modifications orchanges may be made to the above-described system 1000 without departingfrom the intended spirit and scope of the invention. For example,although the preferred embodiment has been shown with a single workinglumen 1020 extending through the deflectable catheter 1010, a pluralityof such lumens may be formed to allow multiple components (e.g., theimaging catheter 112 and the tissue penetrating element 1014 and/or aguidewire (not shown)) to extend through the catheter body 1016simultaneously. However, in many applications it will be desirably tominimize the diameter of the catheter body 1016 and to maximize itspliability or flexibility, thereby rendering it desirable to utilize asingle lumen 1020 in such applications.

Optionally, a side port 1057 may be formed in the rear body portion 1030to permit infusion/withdrawal of fluid through the working lumen 1020 ofthe catheter 1000.

-   v. Markers and Related Apparatus for Positioning/Aiming The    Passageway Forming Catheters

FIGS. 4 d-6 c show various markers and other apparatus which may beincorporated into any of the passageway forming catheters described inthis patent application or any other suitable catheter, to provide ameans for visually determining (e.g., by intracorporeal:imaging such asintravascular ultrasound, or by extracorporeal imaging such asfluoroscopy) the precise positioning and rotational orientation of thedistal portion of the catheter and/or for precisely aiming thetissue-penetrating element so that it will create the desiredinterstitial passageway as it is passed out of the passageway-formingcatheter.

In particular, FIGS. 4 d-4 e show markers which are particularlysuitable for use on passageway-forming catheters which have a stepped orslanted distal end configuration, such as that of the torqueablecatheters shown in FIG. 4 a. The remaining showings of FIGS. 4 g-6 cshow markers and guidance/aiming apparatus which are useable withpassageway-forming catheters which have various distal endconfiguration.

Referring to FIG. 4 d, there is shown a distal portion of apassageway-forming catheter 100 hereupon a generally U-shaped marker 180is mounted on the upper surface of the lower catheter body, distal tothe tissue-penetrating outlet opening 134. The longitudinal midline ofthe marker 180 is in alignment with the path which will be followed bythe tissue penetrating element 150 as it is advanced out of the opening134 in the catheter 100. In this manner, an imaging apparatus such as anIVUS catheter positioned within the lower catheter body portion at avantage point distal to the distal end of the tissue-penetrating elementoutlet opening 134, may be utilized to ensure that the marker 180 is indirect alignment with the target tissue prior to advancement of thetissue penetrating element 150 out of the opening 134.

FIG. 4 e shows a passageway forming catheter 100 having a marker strip182 mounted on the upper portion of the lower catheter body, distal tothe location of the tissue-penetrating element outlet opening 134. Thismarker strip 182 creates an image artifact which extends out radially toallow *point* in a specific direction which corresponds to the path ofthe tissue penetrating element. The longitudinal midline of this markerstrip 182 is in alignment with the path which will be followed by thetissue-penetrating element 150 as it passes out of the opening 134. Inthis manner, an imaging apparatus such as an IVUS catheter positionedwithin the lower catheter body portion at a vantage point distal to thedistal end of the tissue-penetrating element outlet opening 134, may beutilized to ensure that the marker strip 184 is in direct alignment withthe target tissue, prior to advancement of the tissue penetratingelement 150 out of the opening 134.

FIG. 4 f shows a wire marker 186 mounted on the distal portion of apassageway-forming catheter 100 which has an optional imaging window 101formed in the lower catheter body, distal to the tissue-penetratingelement outlet opening 134. The details of this imaging window werepreviously described in applicant's earlier-filed U.S. patentapplication Ser. No. 08/730,496. The wire marker 186 comprises a single,elongate wire which is attached at its opposite ends, to the proximaland distal boarders of the window 101. The elongate wire marker 186 ispreferably in the center of the window 101 and in alignment with thepath which will be followed by the tissue penetrating element 150 as itis advanced out of the opening 134 in the catheter 100. In this manner,an imaging apparatus such as an IVUS catheter positioned within thelower catheter body portion so as to obtain an image through the imagingwindow 101, may be utilized to ensure that the marker wire 186 is indirect alignment with the target tissue prior to advancement of tissuepenetrating element 150 out of the opening 134.

FIG. 4 g shows another passageway-forming catheter 100′ which has animaging lumen 300 through which an imaging catheter may be advanced, anda working lumen 302 through which a tissue-penetrating element 150 maypass, such working lumen 302 terminating distally in an outlet opening134 formed in the side of the catheter 100′ at a spaced distanceproximal to the distal end of the imaging lumen 300, as shown. A pliabledistal tip member 189 is mounted on the distal end of the catheter 100′,and the imaging lumen 300 extends through such tip member 189 andterminates in a distal opening formed therein. Additionally, a hollowpassageway 191 extends longitudinally through such tip member 189 indirect alignment with the main portion of the working lumen 302. Animagable marking wire member 188, preferably formed of a combination ofplatinum and stainless steel, extends through the hollow passageway 191in the tip member 189, and is surrounded laterally by a gap or space 193within such passageway 191, as shown. The proximal end of this wiremember 188 is embedded in a mass of imagable material 190 located withinthe body of the catheter 100′. Such mass of imagable material 190 ispreferably a mixture of tungsten and a plastic (e.g., Pebax) orplatinum. The distal end of the wire member 188 protrudes out of andbeyond the distal end of the catheter body, as shown.

FIGS. 4 h-4 h′ show another passageway-forming catheter 100″ comprisingan elongate pliable catheter body having an imaging lumen 300 and aworking lumen 302. An imaging apparatus, such as IVUS catheter, isadvanceable through the imaging lumen 300. A tissue penetrating element(not shown) is passable through the working lumen 302 and out of theoutlet aperture 134. A marker wire lumen 314 extends through a distalportion of the catheter 100″ between a proximal opening 316 formed inthe upper wall of the imaging lumen 300, and a distal outlet aperture318 formed in the distal end of the catheter 100″, above the distal endoutlet 320 of the imaging lumen 300. A marker wire 310 is disposedwithin the imaging wire lumen 314. A proximal bulb 322 is formed on theproximal end of the marker wire 310, and an optional distal bulb 324 maybe formed on the distal end thereof. Initially, the marker wire 310 isfully retracted into the marker wire lumen 314 such that its distal tipand any distal bulb 324 is wholly contained within the body of thecatheter 100″, and with the proximal bulb 322 protruding slightly intothe imaging lumen 300. The marker wire may be spring loaded or otherwisebiased to this proximally retracted position. Thereafter, when an IVUScatheter is advanced through the imaging lumen 300, the distal end ofthe advancing IVUS catheter will drive the proximal bulb 322 of themarker wire 310 into a proximal cavity 326 formed at the proximal end ofthe marker wire lumen 314, thereby advancing the marker wire 310 suchthat a portion of the marker wire and its distal bulb 322 extends out ofthe distal end outlet aperture 318 and protrudes beyond the distal endof the catheter 100″, as shown in FIG. 4 h. The distal bulb 322 and alongitudinal axis of the marker wire 310 are in direct with the pathwhich will be followed by a tissue-penetrating element (not shown) as itpasses out of the outlet aperture 134. Thus, when the distal bulb 322 ofthe distally advanced marker wire 310 is in direct alignment with thetarget tissue on the image received by the IVUS catheter, such willensure that when the tissue penetrating element is advanced out theoutlet aperture 134, it will be properly aimed and will advance into thetarget tissue, as desired.

FIGS. 4 i and 4 i′ show another passageway-forming catheter 100′″ havingan imaging lumen which terminates in a distal outlet aperture 320 and aworking lumen which terminates in a side outlet aperture 134. An imagingcatheter, such as an IVUS is advanceable through the imaging lumen, anda tissue-penetrating element (not shown) is advanceable out of the sideoutlet aperture 134.

In the particular embodiment shown in FIG. 4 i, an arcuate wire marker330 is mounted on the distal end of the catheter 100′″, in a generallyhorizontal plane, above the distal out end outlet 320 of the imaginglumen 300. This arcuate wire marker 330 may be imaged by the transducerof an imaging catheter which protrudes out of the distal end outlet 320,and a specific, region of the artifact or image produced by the arcuatewire marker 330 may be fused, aimed or aligned with the target tissue,taking into account the distance between the catheter 100 and the targettissue, thereby ensuring that when the tissue penetrating element (notshown) is advanced out of aperture 134 it will extend into the intendedtarget anatomical location or tissue.

In the alternative embodiment shown in FIG. 4 i′, there is provided a3-legged wire marker 332 mounted on the distal end of the catheter100″′. Such 3-legged wire marker 332 comprises bottom legs 334 formed ofsingle wire strands and an upper leg 336 formed of a single wire strandadditionally having an outer wire coil formed therearound. The singlewire strand and the outer wire coil may be formed of differentmaterials. The upper leg 336 is in direct longitudinal alignment withthe half which will be followed by the tissue penetrating element as itpasses out of the side outlet aperture 134 of the catheter 100″′. Inthis manner, when an imaging catheter such as an IVUS is advanced out ofthe distal end opening 320 of the imaging lumen, it may be utilized todirectly align the upper leg 336 of the three-legged wire marker 322with the intended target tissue; thereby insuring that when the tissuepenetrating element is passed out of the side outlet aperture 134, itwill form the desired passageway into the target tissue.

FIGS. 4 j-4 j′ show a passageway forming catheter 100′″ having the sameconfiguration as that of FIGS. 4 i-4 i′, but wherein a deflectable wiremarker 340 is mounted on the end of the catheter 100″′, as shown. Suchdeflectable wire marker 340 preferably comprises a singe wire strandhaving an additional wire coil formed therearound. This deflectable wiremarker 340 has a top end 342 which is attached to the body of thecatheter 100′″ at a site which is in direct longitudinal alignment withthe side outlet aperture 134. When the deflectable wire marker 340 is inits non-deflected position (FIG. 4 j) its bottom end 344 will protrudedownwardly over the distal end outlet 320 of the imaging lumen 300.Thus, when an imaging catheter such as an IVUS catheter is advancedthrough the imaging lumen 300 and out of the distal end outlet aperture320 it will abut against the bottom portion of the deflectable wiremarker 340, thereby causing the deflectable wire. marker 340 to assume adeflected position as shown in FIGS. 4 j′. When the deflectable wiremarker 340 is in such deflected position, the longitudinal axis of thedeflectable wire marker 340 will be in direct alignment with the pathwhich will be followed by the tissue penetrating element (not shown) asit is passed out of the side outlet aperture 134. In this manner, theimaging catheter (IVUS) may be utilized to directly align thelongitudinal axis of the deflectable wire marker 340 with the targettissue, thereby insuring that when the tissue penetrating element ispassed out of the side outlet aperture 134 it will form the desiredinterstitial passageway into the target tissue.

FIG. 4 k shows the same tissue-penetrating catheter 100″′ wherein asecondary guidewire lumen 348 extends longitudinally through the body ofthe catheter 100′″, from a proximal aperture 350 formed in the distalcurved surface of the working lumen 302 to a distal guidewire outletaperture 352 formed in the distal end of the catheter body, as shown. Inthis embodiment, the tissue penetrating element 150′ comprises anelongate member having a sharpened distal end and a hollow guidewirelumen extending longitudinally therethrough. A guidewire 356 isadvancable through the guidewire lumen of the tissue penetrating element150′. When the tissue penetrating element 150 is retracted into theworking lumen 302 as shown in FIG. 4 k, the guidewire 356 may beadvanced out of the distal end of the tissue penetrating element 150,through the secondary guidewire lumen 348, wherein it will act as amarker which may be imaged by a imaging apparatus (e.g., an IVUScatheter) passed through the imaging lumen 300. The longitudinal axis ofthe guidewire 356, when positioned within the secondary guidewire lumen348, will be in direct alignment with the path which will be followed bythe tissue penetrating element 150 as it is advanced out of the sideoutlet aperture 134.

The showing of FIG. 4 k also incorporates a separate image-enhancingmeans whereby energy (e.g., ultrasonic vibration) may be imparted to thetissue penetrating element 150′ as it is advanced out of the side outletaperture 134 to render the distal portion of the tissue penetratingelement 150′ more easily visible by the imaging apparatus (e.g., IVUScatheter) positioned in the imaging lumen 300. This is accomplished byan energy emitting member 370, such as an ultrasound generating deviceis mounted in the wall of the catheter 100′″, about the side outletaperture 134. A connector wire 372 extends longitudinally through thecatheter 100′″ to its proximal end, to permit the energy-emittingapparatus 370 to be connected to an appropriate source of energy. As thetissue penetrating element 150′ is advanced out of the side outletaperture 134, the energy emitting apparatus 370 is energized via theconnector wire 372, thereby imparting energy to the distal portion ofthe tissue penetrating element and enhancing its visibility by theimaging apparatus positioned within the imaging lumen 300. One exampleof an ultrasound emitting chip which may be used as the energy emittingapparatus 370 such as a piezoelectric crystal of the type generallyknown in the art as a PZT crystal (lead-zirconate titanate).

FIG. 41 shows a passageway-forming catheter 100′″ of the same generalconfiguration shown in FIGS. 4 i-4 k, but wherein at least a portion ofthe imaging lumen 300 is of non-round configuration. In the preferredembodiment shown, the imaging lumen 300 is of rectangular configurationhaving a longitudinal groove 373 extending along the upper surfacethereof, as shown. A correspondingly shaped engagement member 378 isformed on the catheter 374 and such engagement member incorporates alongitudinal tongue 379 which fits slidably into the correspondinggroove 373. In this manner, the catheter 374 can be, inserted only inthe desired rotational orientation, as shown. A phased array imagingcatheter 374 having a phased array imaging transducer 376 mountedthereon is advanceable through the imaging lumen 300 of the catheter100′″. The irregularly shaped or non-round engagement member 378 formedon the outer surface of the phased array imaging catheter 374 and isconfigured to frictionally engage the wall of the imaging lumen 300 toprevent the phased array imaging catheter 374 from rotating within theimaging lumen 300. An electronic marker is formed within the circuitryof the phased array imaging catheter 374 so as to mark a desiredlocation L which is in direct alignment with the outlet aperture 134 ofthe catheter 100′″ when the phased array imaging catheter 374 isnon-rotatably inserted into the imaging lumen 300. In this manner, theelectronically marked location L may be placed in direct alignment withthe target tissue viewed on the image received through the phased arrayimaging catheter 374, thereby insuring that the outlet aperture 134 isalso in alignment with the target tissue. It should be appreciated, thatas an alternative to internally or electronically marking the desiredlocation L on the phased array transducer 376, various imagable markersmay be formed on the body of the catheter 100′″ to mark the rotation ofthe outlet aperture 134, examples of such imagable markers beingdescribed hereabove and shown in FIG. 4 d-4 k.

One example of an electrical system which may be utilized toelectronically mark a desired location L on the image received from thephased array transducer 376 is shown, in schematic fashion, in FIG. 4l′. With reference to FIGS. 4 l and 4 l′, the phased array transducer376 of the phased array imaging catheter 374 has a plurality ofindividual crystals 900 formed at spaced-apart locations on thetransducer 376. Wires 902 extend from each of the individual crystals900 of the phased array transducer 376, through the body of the phasedarray imaging catheter 374 and out of the proximal end thereof. One ofthese individual wires 902 a is separated from remaining wires 902 b,and the remaining wires 902 b extend directly into a monitoring console904 which produces the viewable image from the phased array transducer376. The selected wire 902 a is connected to a switch 906. When theswitch 906 is in its open position, the signal received from theselected wire 902 a will be shunted through a bypass circuit 908 whichrejoins the remaining wires 902 b prior to entry into the monitoringconsole 904. In this manner, when the switch 906 is open, the signalreceived from the selected wire 902 a will bypass the signal modifyingapparatus 903 and will rejoin the signals received from the remainingwires 902 b to provide an image on the image monitoring console 904which is unchanged and unmarked. However, when the switch 906 is closed,the signal received from the selected wire 902 a will pass through asignal modifying apparatus 903. This signal modifying apparatus 903 maysimply be an open switch which terminate the signal, thereby providing avoid in place of the image which would be displayed from the individualcrystal 900 from which the selected wire 902 a extends. Alternatively,such signal modifying apparatus 903 may be a saturation apparatus whichwill produce white noise, or a color imparting apparatus which will tintor color the image received from the selected wire 902 a. In eithercase, the image which subsequently appears on the image monitoringconsole 904 from the selected crystal 900 from which the selected wire902 a extends will be visually discernable by the operator and willprovide a marking of the desired location L on the. phased array imagingtransducer 976.

FIGS. 4 m and 4 m′ the presently preferred embodiment comprising acatheter 100″″ wherein a segment of the catheter body is cut away, witha plurality (e.g., (three (3)) struts 402, 404, 406 formed a connectionbetween a proximal portion 408 of the catheter 100″″ and a distalportion 410 thereof, so as to form an imaging cage wherein the imagingcatheter (e.g., IVUS) may be positioned. The top strut member 404 is ofelongate configuration, and it longitudinal axis is directly alignedwith the side outlet aperture 134 through which the tissue penetratingelement will pass. In this manner, when an imaging catheter is passedthrough the imaging lumen 300 such that its imaging transducer islocated within or distal to the open area 400, such imaging catheter maybe utilized to directly image the upper strut 404 and the catheter body100″″ may be rotated until the upper strut 404 is in direct alignmentwith the image of the intended target tissue, thereby insuring that whenthe tissue penetrating element passes out of the side outlet aperture134 it will form the desired interstitial passageway into the targettissue. Optionally, a pliable, hollow tip member 412 may be mounted onthe distal end of the catheter 100″″. In the embodiment shown in FIG. 4m the optional tip member 412 is a frusto conical configuration, whilein the embodiment of FIG. 4 m′ the tip member 412′ is of hemisphericalconfiguration. It will be appreciated that this cage-like structure maybe formed in many ways including by EDM technology or by forming thestruts 402, 406, 408 of individual wires.

Any of the above-described markers shown in FIGS. 4 d-4 m′ mayincorporate regions thereon or discrete markings formed thereon, eachsuch region or discrete marking being correlated to a specific range ordistance from the catheter 100 to the anatomical target location. Inthis manner, the imaging apparatus (e.g., IVUS catheter) may beselectively used to align a specific region or distance-correlatedmarking on the marker with the target anatomical locations, based on theoperator's knowledge, estimate or calculation of the range or distancefrom the catheter 100 to the target anatomical location. Additionally oralternatively, in embodiments wherein the imaging apparatus is mountedon a catheter which is insertable through an imaging lumen 300 in thepassageway-forming catheter 100, the passageway forming catheter 100 maybe provided with length markings or friction-producing regions withinthe imaging lumen 300 to provide increased resistance or some othertactile sensation whereby the operator may judge the length of theimaging catheter (e.g.; IVUS catheter) which has been advanced throughthe imaging lumen 300 and the present location of the imaging transduceror other image receiving apparatus thereon. In this manner, the operatormay precisely position the imaging transducer or image receivingapparatus at a specific location (e.g., extended out of the distal endopening 320 and immediately distal to the distal end of the catheter100) which provides the optimal vantage point for visualization of thetarget anatomical structure and marker, and for resultant aiming of themarker by rotational and longitudinal adjustment of the catheter 100.

Any of the imageable Markers described herein, including but limited tothose shown in FIGS. 4 d-4 m, may be formed of materials which affectthe form of energy which is sensed by the imaging apparatus or catheter(e.g., ultrasound being received by an IVUS catheter) to modify orenhance the artifact created by the marker. For example, any of thesemarkers may be formed of material (e.g., soft plastic having lowacoustic impedance) which is absorptive of the ultrasound or otherenergy form received by the imaging apparatus and, therefore, willappear as a void or black area on the image screen. Similarly, thesemarkers may be formed of material (e.g., metals or alloys such asstainless steel, beryllium, or Nitinol) which is partially internallyreflective of the energy form so as to give rise to an artifact (e.g., astreak or ray) which appears to emanate from in one or more directionsfrom the exact location of the marker. In this manner, the marker may bepositioned at a precise location and may be formed of material which ispartially internally reflective such that an artifact (e.g., a ray orstreak) is formed on the image screen which directly correlates to thepath which will be followed by the tissue-penetrating element, suchartifact (e.g., ray or streak) being useful to enable the operator todetermine the precise path which will be followed by the tissuepenetrating element. In other applications, the marker may be formed ofmaterial which is reflective of the energy form such that a bright spotor exaggerated area will appear on the image screen when such marker issurrounded by tissue or other matter which is less then totallyreflective of the energy form. Thus, in addition to the above-describedmethods for modifying the markers by applying energy (e.g., ultrasound)to the body of the marker, the exact form of the image or artifactproduced by the marker may also be altered or optimized by forming themarker of a particular material of varied acoustic impedance, rangingfrom air or fluid filled cavities, to solid materials, to produce arange of marker effects on the image produced.

FIG. 5 shows an alternative positioning-aiming system which is useableto facilitate precise positioning and aiming of the passageway formingcatheter 100 a. In this system, a signal emitting apparatus 500 ispositioned in the target area (e.g., within a second blood vessel BV₂)and a signal receiving apparatus 502 is mounted within thepassageway-forming catheter 100 a located within in a first blood vesselBV₁. The signal emitting apparatus 500 comprises a signal emitting wire504 having a tubular shield 506 surrounding the shaft of the wire suchthat only a distal portion 508 of the wire 504 extends out of the distalend of the shielding tube 506. The shielding tube 506 may comprise anysuitable electromagnetic shielding material, and is preferably formed ofa pliable plastic tube having an aluminum braid formed therein. Thoseskilled in the art will appreciate that the signal emitting wire 504 maybe attached to an extracorporeally located signal generating apparatuscapable of passing an electromagnetic signal through the wire 504. Suchelectromagnetic signal may be a 20 Khz signal.

The signal receiving apparatus 502 is preferably formed within the wallof the passageway forming catheter 100 a laterally outboard of theworking lumen 302 through which the tissue penetrating element ispassed, and in direct alignment with the tissue penetrating elementoutlet aperture 134 formed in the side of the catheter 100 a.Optionally, the catheter 100 a may also include an imaging lumen 300through which and imaging catheter (e.g., an IVUS catheter) may bepassed. However, those skilled in the art will appreciate that in manyapplications the signal emitting apparatus 500 and signal receivingapparatus 502 will be operable to control the precise positioning androtational orientation of the catheter 100 a, and such imaging lumen 300may be unnecessary.

The signal receiving apparatus 502 formed in the passageway-formingcatheter 100 a comprises a signal receiving wire 510 having a tubularshielding apparatus 512 formed therearound. The tubular shieldingapparatus 512 surrounds the shaft of the receiving wire 510 and a shortdistal portion 514 of the receiving wire 510 extends out of and beyondthe distal end of the tubular shield 512. The tubular shield 512 may beformed in the same manner as the above-described tubular shield 506 ofsignal emitting apparatus 500. The exposed distal portion 514 of thesignal receiving wire 510 is located immediately adjacent, and inlongitudinal alignment with the side outlet aperture 134. In thismanner, an electro magnetic signal may be emitted through the signalemitting apparatus 500 after it has been positioned within the secondblood vessel BV₂ or other target tissue. The longitudinal positioningand rotational orientation of the passageway-forming catheter 100 ainserted within the first blood vessel BV₁ may then be adjusted untilthe signal received by the signal receiving apparatus 502 of thecatheter 100 a is at its peak intensity, thereby indicating that theexposed distal portion 514 of the receiving wire 510 has been positionedat its closest possible point to the exposed distal portion 508 of thesignal emitting wire 504. This will ensure that the passageway formingcatheter 100 a is longitudinally positioned at the closeststraight-lined point from the signal emitting apparatus 500 locatedwithin the second blood vessel BV₂ or other target tissue, and that thecatheter 100 a has been rotated to a rotational orientation wherein theoutlet aperture 134 is directly aimed at the signal emitting apparatus500 located within the second blood vessel BV₂ or other target tissue.It will be further appreciated by those skilled in the art that varioustypes of energy-emitting signals may be utilized into, such that thesignal emitting apparatus 500 located within the second blood vessel BV₂or target tissue is an “active” element and the signal receivingapparatus 502 associated with the passageway forming catheter 100 a is a“passive” or receiving element. The types of signals which may beutilized include, but are not necessarily limited to, electromagneticsignals (as specifically described hereabove), sonic signals (e.g.,doppler), ultrasonic signals, high intensity light, laser,radiofrequency, etc.

FIG. 5 a shows another positioning/aiming system which is whollyincorporated into the passageway-forming catheter 100 b. A signalemitting or “active” component 520, such as a piezoelectric crystal ismounted upon or formed within the catheter 100 b so to emit a signal orflow of energy which will strike, enter or be reflected from the targettissue T. A passive or receiving apparatus, such as anotherpiezoelectric crystal may be mounted at a second location within or uponthe catheter 100 d so as to receive a reflected signal or returningsignal from the target tissue T. The position of the passive orreceiving apparatus 522 relative to the active or emitting apparatus 520is known, and may be utilized to precisely determine the longitudinalposition and rotation orientation of the catheter 100 b. In this manner,this positioning/aiming system may be utilized to effect preciselongitudinal positioning and rotational orientation of the catheter suchthat when the tissue penetrating element is passed out of the outletaperture 134, it will extend into the target tissue T, as desired. Thoseskilled in the art will appreciate that, as an alternative to thepassive receiving apparatus 522, or in addition thereto, an optionalimaging lumen 300 may extend through the body of the catheter 100 b suchthat an imaging catheter (e.g., IVUS catheter or receiving cathetercarrying the passive receiving apparatus 522 may be passed through suchlumen 300 and utilized to alternatively or additionally facilitate thepositioning and rotational orientation of the catheter 100 b.

FIG. 5 b shows yet another alternative positioning/aiming system whereina signal emitting crystal 530 is positioned on or within the catheter100 c so as to emit a signal (e.g., ultrasound or sound waves) in adirection which is specifically aligned with the path which will befollowed by the tissue penetrating element as it passes out of the sideoutlet aperture 134 an imaging catheter. An imaging catheter (e.g., anIVUS catheter) positioned within the imaging lumen 300 is utilized toreceive the signal from the crystal 530 after it has reflected from thetarget tissue T, thereby discerning the specific point of impingement Xon the target tissue T where it is struck by the energy being emitted bythe signal emitting crystal 530. In this manner, the imaging catheterpositioned within the imaging lumen 300 may be utilized, to preciselyposition and aim the outlet aperture 134 of the passageway-formingcatheter at the energy impingement point X on the target tissue T,thereby insuring that, when the tissue penetrating element is advancedout of the outlet aperture 134, it will extend into the target tissue Tat a desired site.

Further referring to FIG. 5 b, the signal emitting crystal 530 may bealternatively utilized as a signal receiving crystal, such that it willreceive reflected ultrasound from the. IVUS, as indicated by the dottedarrows on FIG. 5 b. Since the signal receiving crystal 530 isspecifically positioned and oriented in relation to the outlet 134and/or path of the tissue penetrating element 150, such receipt of theIVUS ultrasound by the signal receiving crystal 530 will enable theoperator to precisely position and rotationally orient the catheter suchthat the tissue penetrating element 150 will pass directly into thetarget tissue T, in parallel to the path of reflected ultrasoundreceived by the signal receiving crystal 530.

FIG. 5 c shows yet another positioning/aiming system wherein thepassageway-forming catheter 100 d has a working lumen 302 whichterminates in a side outlet aperture 134 and through which atissue-penetrating element 500 in the nature of an elongate member 540having a sharpened distal end may be advanced through such working lumen302 and out of the side outlet aperture 134 of the catheter 100 d. Theelongate member 540 in this embodiment is equipped with a sensorapparatus 548 positioned at or near the sharpened distal end of theelongate member 540. A connector wire 550 may extend longitudinallythrough the elongate member 540 to permit the sensor 548 to send asignal through the shaft of the member 540 to an extracorporeal locationat which such signal may be processed and/or monitored. The sensor 548may be any suitable type of sensor which will sense the presence and/orlocation of the intended target tissue T. Parameters or variables whichmay be sensed by the sensor 548 include temperature, pulse, flow, orother characteristics of the target tissue T, capable of beingmechanically, electronically or optically sensed. Additionally oralternatively, an energy emitting or “active” apparatus, such as theenergy emitting apparatus 500 described hereabove with reference to FIG.5, may be positioned within the target tissue T and the sensor 548formed on the tissue penetrating member 540 may be adapted to receiveand sense energy emitted by the active energy emitting member locatedwithin the target tissue T. In this manner, the tissue penetratingmember 540 serves its own sensing function and enables the operator tocontrol the longitudinal and rotational position of the catheter 100 dprior to or during the advancement of the tissue penetrating member 540out of the outlet aperture 134 and into the target tissue T. It will beappreciated by those skilled in the art, when a tissue penetratingmember 540 having an onboard sensor 548 of the type described herein isutilized, such will eliminate the need for any other extracorporeal orintracorporeal imaging or sensing apparatus for aiding in positioning orrotational orientation of the catheter 100 b. Alternatively, thecatheter 100 b may also be provided with other onboardaiming/positioning apparatus or an imaging lumen 300 as described inreference to various other embodiments shown in FIGS. 4-5.

FIG. 5 d shows another aiming/positioning system which is similar tothat shown in FIG. 5 b, but wherein the emitting member 530 (e.g., anultrasound emitting piezoelectric crystal) is aimed downwardly at thetransducer or receiving port of the imaging catheter (e.g., catheter),and the emitting member 530 is specifically positioned relative to theoutlet opening 134 so as to provide an imageable marking at the outletopening 134. In this manner, the imaging catheter (IVUS catheter) may beused to specifically site and identify the location of the outletaperture 134, thereby facilitating longitudinal positioning androtational aiming of the catheter prior to deployment of the tissuepenetrating member 150.

FIG. 5 e shows one embodiment of a system 790 which may be utilized tofacilitate optimization or peaking of the signal received from a sensoror receiving component which is utilized to position and aim thecatheter, such as those described hereabove and identified by referencenumerals 502, 522, 530 and 548. In this system 790, the wire 510, 521,531, 550 through which a signal is received from the receiving component502, 522, 530, 548 is connected to a switch 818. When the switch 818 isopen, the signal received will not enter the system 790. However, whenthe switch 818 is closed, the signal received from the receiving orsensing component 502, 522, 530, 548 will enter a signal conditioningand filtering component 880 wherein the signal will undergo conditioningand filtering. Thereafter this signal will pass through a rectifier 810wherein the signal will be rectified, and through a leaky integrator 812of the type well known in the art. Such leaky integrator 812 maycomprise a capacitor and a resistor in parallel. The integrated signalfrom the leaky integrator 812 may then pass into an analog to digitalconvertor 814, if desired, whereby it will be converted to a digitalsignal, and such digital signal will then be fed to a display 816 of atype suitable for indicating the relative intensity of the signalreceived. Such display may be an LED or multiple light display, wherebya column or array of lights are provided and the intensity of the signalreceived is indicated by the height of the column or the number oflights in the array which are lit at any given time.

In this manner, the system 790 shown in FIG. 5 d may be utilized toenable the operator to longitudinally and rotationally move the catheteruntil the signal received from the receiving component or sensor 502,522, 530, 548 has been peaked or optimized, thereby indicating that thecatheter is properly positioned such that the tissue penetrating elementwill extend from the outlet 130 into the target anatomical location T.

FIGS. 6-6 c show other catheter marking schemes which may be used inconjunction with an extracorporeal imaging apparatus 118, such as afluoroscope, positioned adjacent a mammalian body MB. In the showing ofFIG. 6, a catheter 100 has been advanced into the blood vessel BV₁, andsuch catheter is marked with one of the marking schemes of thisembodiment of the present invention. FIGS. 6 a-6 c show the manner inwhich the marking scheme of the catheter 100 will appear on thefluoroscopy screen 120 as the catheter is rotated within the bloodvessel BV₁.

Referring to FIG. 6 a, there is provided a marking scheme whichcomprises a first radio-opaque linear marking 122 on one side of thecatheter body, and a second radio-opaque linear marking 122 b. Thesecond linear marking 122 b is located directly and 180° opposite thefirst linear marking 122 a, but slightly more distal to the firstmarking 122 a. An additional rotation indicating indicia 200, comprisingthe letter “R” formed of radio-opaque or other imagable material, isformed to the right of the first linear marking 122 a. As shown in FIG.6 a, when the catheter is in its desired rotational orientation, thefirst and second linear markings 122 a and 122 b will appear next to andin linear alignment with one another on the fluoroscopy screen 120. Whensuch markings 122 a and 122 b are viewed from the right side RS of thecatheter body the rotational marking indicia 200 will appear as theletter “R”. However, when the catheter is rotated 180° such that thefluoroscope 118 views the catheter from the left side LS of the catheterbody, the rotational marking indicia 200 will appear as the invertedmirror image of the letter “R”, thereby informing the operator that thecatheter is rotated 180° from the desired rotational orientation.

FIG. 6 b shows a similar marking scheme wherein the rotational markingindicia 200 is formed adjacent a radio-opaque circle 24 formed on theright side RS of the catheter body such that, when the catheter body isin its desired rotational position, a radio-opaque dot 126 formed on theleft side LS of the catheter body will appear within the circle 124 onthe fluoroscopy screen 120, and the rotational marking indicia 200 willappear as the letter “R” to the right of the radio-opaque circle 124.However, when the catheter body is rotated 180° such that thefluoroscope 118 is viewing the left side LS of the catheter body, therotational marking indicia 200 will appear as the inverted mirror imageof the letter “R” on the left side of the circular marking indicia 124,as illustrated in FIG. 6 b.

Similarly, as shown in FIG. 6 c, the catheter 100 may be provided withtwo (2) through holes 128 a, 128 b formed in direct linear alignmentwith one another on opposite sides of the catheter 100. Adjacent one ofthe through holes is an imageable marker in the form of the letter “R”.When the catheter 100 is rotated such that the through holes 128 a, 128b are in direct alignment with the extracorporeal imaging apparatus 118,both through holes 128 a, 128 b will appear as a single aperture on theimage provided on the image viewing apparatus 120. However, when thethrough holes 128 a, 128 b are not in direct alignment with one another,they will appear as separate images on the image viewing apparatus 120.In this manner, these through holes 128 a, 128 b may be utilized todiscern the correct rotational orientation of the catheter using anextracorporeal imaging apparatus 118. Similarly, as described hereabove,the letter R will appear differently depending on which side of thecatheter 100 is closest to the imaging apparatus 118, thereby avoidingany possible inadvertent 180° mis-rotation of the catheter.

-   vi. Apparatus for Preventing Inadvertent Deployment of Tissue    Penetrating Element

FIG. 8 shows another embodiment of the catheter 100 e which incorporatesapparatus for preventing inadvertent deployment of thetissue-penetrating element 150. In this catheter 100 e, a lumen closuremember 548 is pivotally mounted on one side of the working lumen 302through which the tissue penetrating element 150 will pass such that,when in an upwardly pivoted position, such member 548 will block thelumen and prevent inadvertent advancement of the tissue penetratingelement out of the opening 134. A balloon 544 or other pressure exertingmember is mounted within the body of the catheter 100 e, adjacent theblocking member 548 in the embodiment shown, a balloon inflation lumen546 extends through the catheter to permit alternate inflation anddeflation of the balloon. In this manner, when the balloon 544 isinflated, as shown in FIG. 8, the member 548 will pivot upwardly so asto block the working lumen 302 in a manner which will preventinadvertent deployment of the tissue penetrating element 150.Alternately, when the balloon 544 is deflated, the member 548 will pivotdownwardly thereby restoring the working lumen 302 to an openconfiguration through which the tissue-penetrating element 150 may pass.

FIG. 8′ shows another embodiment of the catheter 100 e whichincorporates apparatus for stabilizing the catheter within a vesselafter proper orientation has been confirmed. This apparatus alsoprevents inadvertent deployment of the tissue penetrating element 150 incombination with the stabilization. In this catheter 100 e, a lumenclosure member 548′ is pivotally mounted near the working lumen 302through which the tissue penetrating element 150 will pass. The lumenclosure member 548′ is biased or spring loaded by spring member 998 suchthat when the balloon, 544′ or other pressure exerting member isdeflated, lumen 302 is blocked preventing inadvertent advancement of thetissue penetrating element out of the opening 134. A balloon inflationlumen 546 extends through the catheter to permit alternate inflation anddeflation of the balloon. After proper orientation of the catheter 100 ehas been confirmed, the balloon is inflated which causes a portion ofthe balloon to exit the side of the catheter through exit port 999 whichsecures the catheter in place within the vessel, 997 as is shown in FIG.8″. Simultaneous with anchoring the catheter in place, inflation of theballoon causes lumen closure member 548′ to pivot thereby opening theworking lumen 302 to allow advancement of the tissue penetrating element150.

Materials, construction and treatments of the balloon, 544′ may be madeto prevent undesired movement or dislodgment in the vessel during itsinflated state. Treatment may include surface modification, Dacron, orother means.

It should be appreciated that the general concept of combining ananchoring device which is deployed after confirmation of properorientation of the tissue penetrating element which simultaneously ornearly thereafter, removes a safety device previously in place toprevent inadvertent advancement of the tissue penetrating element, canbe accomplished in other ways not completely described above.

It will be appreciated by those skilled in the art that the inventionhas been described hereabove with reference to certain presentlypreferred embodiments and examples only, and no effort has been made toexhaustively describe all possible embodiments and examples in which theinvention may take physical form. Furthermore, it will be appreciatedthat each of the specific components and elements of the above-describedembodiments and examples may be combined or used in conjunction with anyof the other components shown in relation to other embodiments orexamples, to the extent such recombination of elements or components maybe accomplished without rendering the device, apparatus, or systemunusable for its intended purpose. Furthermore, various additions,deletions, modifications, and alterations may be made to theabove-described embodiments and examples without departing from theintended spirit and scope of the invention. Accordingly it is intendedthat all such variations, recombination, additions, deletions andmodifications be included within the scope of the following claims.

1. A torqueable sheath which is insertable into a mammalian body anduseable to rotationally position of the distal end of a catheter whichhas been inserted through the sheath; said sheath comprising: a pliabletubular sheath body having a proximal end, a distal end and a hollowlumen extending longitudinally therethrough, said tubular sheath bodyhaving sufficient torque strength to transfer torque from the proximalend thereof to the distal end thereof, such that the distal end of thesheath body will rotate in substantial correlation with the proximal endof the sheath body; a catheter engaging surface formed within the lumenof the sheath body, said catheter engaging surface being operative toengage the catheter when the catheter has been inserted through thesheath, such that i) the catheter will be prevented from rotatingindependently of the introducer sheath, but ii) at least the distal endof the catheter will be caused to rotate in unison with the sheath. 2.The torqueable sheath of claim 1 wherein said tubular sheath body isformed of a polymeric material having reinforcement members disposedtherein to increase the torque strength of said polymeric material. 3.The torqueable sheath of claim 2 wherein said reinforcement members areformed into a braid.
 4. torqueable sheath of claim 3 wherein said braidis formed of first and second groups of elongate members, each of saidgroups of elongate members being made up of a plurality of individualelongate members arranged in substantially parallel, side-by-siderelation to one another, said first group being wound about the lumen ofthe sheath body in a clockwise direction, and said second group beinghelically wound about the lumen of the sheath body in a counterclockwisedirection, such that the elongate members of the first group cross withthe elongate members of the second group at a plurality of cross-overlocations, the individual elongate members of the first group beingalternately passed over and under the individual elongate members of thesecond group at said cross-over locations, so as to form a tubular braidabout the lumen of said sheath body.
 5. An achorable guide catheterwhich is insertable into a luminal anatomical structure, said guidecatheter comprising: a elongate catheter body having at least one lumenextending longitudinally therethrough; an opening formed at a firstlocation in said catheter body, in communications with said at least onelumen; a pressure exerting member formed on said catheter body, saidpressure exerting member being engageable with the luminal anatomicalstructure to prevent the first location of the catheter body from movingwithin the luminal anatomical structure.
 6. The anchorable guidecatheter of claim 5 wherein said pressure exerting member is a balloon,and wherein said balloon is inflatable such that it will engage theluminal anatomical structure to prevent the first location of thecatheter from moving within said luminal anatomical structure.
 7. Theanchorable guide catheter of claim 6 wherein said balloon includes afriction enhancing treatment upon a surface of the balloon which engagesthe luminal anatomical structure.
 8. The anchorable guide catheter ofclaim 7 wherein said friction enhancing treatment on said balloon isselected from the group of friction enhancing treatments consisting of:texturing; adhesive; and, woven fabric.
 9. The anchorable guide catheterof claim 5 further comprising: at least one engagement surfaceassociated with said first lumen, said at least one engagement surfacebeing operative to engage a second catheter which has been insertedthrough said first lumen such that said second catheter is therebyprevented from rotating independently of said balloon-anchorable guidecatheter.
 7. The anchorable guide catheter of claim 9 in combinationwith at least a) an imaging catheter and b) a passageway formingcatheter having a tissue-penetrating element which is passable throughthe wall of the luminal anatomical structure within which theballoon-anchorable guide catheter is positioned, said anchorable guidecatheter being useable in conjunction with said imaging catheter andsaid passageway-forming catheter to form said passageway through thewall of the luminal anatomical structure, at a predetermined location,by the following steps: i) transluminally advancing the guide catheterinto said luminal anatomical structure until the opening of the guidecatheter is near the location on the luminal anatomical structurethrough which said passageway is to be formed; ii) inserting the imagingcatheter into a lumen of the guide catheter such that the imagingcatheter will image anatomical structures which are in alignment withthe opening of the guide catheter; iii) moving the guide catheter untilthe image obtained by the imaging catheter indicates that the opening ofthe guide catheter is in alignment with the site at which theextravascular passageway is to be formed; iv) causing the pressureexerting member to engage the luminal anatomical structure 10 as to holdthe first location of the guide catheter in substantially fixedposition; v) removing the imaging catheter from the first lumen of theguide catheter; vi) inserting the passageway-forming catheter into alumen of the guide catheter such that the passageway-forming catheterengages the at least one engagement surface of the guide catheter; vii)causing the tissue-penetrating element to pass out of thepassageway-forming catheter, through the opening of the guide catheter,and through the wall of the luminal anatomical structure, therebyforming said passageway:
 8. The anchorable guide catheter of claim 7wherein the pressure exerting member is an inflatable balloon, andwherein the step iv) comprises inflating the balloon such that theballoon will engage the luminal anatomical structure.
 9. In apassageway-forming catheter of the type haying i) an elongate catheterbody and ii) a tissue-penetrating element which is advanceable out of afirst location on the elongate catheter body so as to pass through thewall of a luminal anatomical structure and to a target location in whichsaid catheter is positioned, and iii) an imaging means which is useableto image the target location, the improvement comprising: a markerformed on said catheter at a second location, said second location beingpositioned relative to said imaging means and said first location, suchthat when the position and rotational orientation of the catheter isadjusted such that said marker is aimed at said target location, saidtissue penetrating element will penetrate through the wall of theluminal structure and into said target location.
 10. The catheter ofclaim 9 wherein said marker comprises: a U-shaped member mounted on saidcatheter.
 11. The catheter of claim 9 wherein said marker comprises: anelongate, generally rectangular member mounted on said catheter.
 12. Thecatheter of claim 9 wherein said marker comprises: a elongate wiremounted on said catheter.
 13. The catheter of claim 9 wherein saidmarker comprises an arcuate member attached to and extending distallyfrom the distal end of the catheter body, said arcuate member beingdisposed in a plane which is substantially perpendicular to the path ofthe tissue-penetrating element.
 14. The catheter of claim 9 wherein saidmarker comprises a tripod member mounted on the distal end of thecatheter, said tripod member having first second and third legs attachedto said catheter and to one another, at least one of said legs being inalignment with the path of the tissue penetrating element.
 15. Thecatheter of claim 9 wherein the imaging means comprises an elongateimaging lumen which extends longitudinally through the catheter body andinto which an imaging apparatus is insertable and positionable so as toobtain an image of said marker and said target anatomical structure. 16.The catheter of claim 15 wherein said imaging lumen extendslongitudinally through the catheter and opens through an outlet aperturein the distal end of the catheter, and wherein said imaging apparatus isadvanceable through said lumen such that the imaging apparatus protrudesout of and extends beyond the distal end of the catheter.
 17. Thecatheter of claim 15 wherein said imaging lumen extends longitudinallythrough said catheter and wherein an imaging window is formed at asecond location on said catheter such that an imaging apparatus may beadvanced through said imaging lumen and utilized to obtain an image ofsaid marker and said target anatomical structure, through said imagingwindow.
 18. The catheter of claim 9 wherein said catheter furthercomprises: a flexible tip member mounted on the distal end of thecatheter, said flexible tip member having a hollow passageway extendinglongitudinally therethrough, and wherein said marker comprises anelongate member attached to said catheter body and extending through atleast a portion of the hollow passageway formed in said elongate member.19. The catheter of claim 18 wherein said hollow passageway has a firstdiameter, and wherein said elongate member has a second diameter smallerthan said first diameter, such that a gap surrounds said elongate memberwithin said hollow passageway.
 20. The catheter of claim 18 wherein saidelongate member protrudes beyond the distal end of said distal tipmember.
 21. The catheter of claim 9 wherein said marker comprises: anotch formed within said catheter and surrounded by a plurality of strutmembers, said imaging means being positionable within said notch, and atleast one of said strut members being useable as said marker.
 22. Thecatheter of claim 21 wherein said strut members comprise elongate wiresattached to said catheter body and extending over said notch.
 23. Thecatheter of claim 21 wherein said notch comprises a region which is cutaway from said catheter body such that there is defined a proximalcatheter body portion proximal to said notch, and a distal catheter bodyportion distal to said notch.
 24. The catheter of claim 23 wherein animaging catheter lumen extends longitudinally through said catheterbody, and wherein said imaging means comprises an imaging catheter whichis advanceable through said imaging catheter lumen and into said notchsuch that the image received by said imaging catheter includes the imageof said at least one strut member which is useable as said marker. 25.The passageway-forming catheter of claim 9 wherein said marker is asignal-emitting component which emits a signal which may be detected bysaid imaging means.
 26. The passageway-forming catheter of claim 25wherein said energy-emitting component is a piezoelectric crystal. 27.The catheter of claim 9 wherein the distance from said first location onsaid catheter to said target anatomical structure is known, and whereinsaid marker further comprises: a plurality of distance-specific markerlocations, each said distance-specific marker location being correlatedto a known distance from said first location on said catheter to saidtarget anatomical structure, said imaging means being thereby useable toposition a selected on of said distance-correlated markings in alignmentwith the image of said target anatomical structure, thereby placing thecatheter in optimal position and orientation to cause saidtissue-penetrating element to form the desired passageway to said targetanatomical structure, without extending beyond said target anatomicalstructure.
 28. A system for positioning/aiming a passageway formingcatheter which comprises an elongate catheter body having atissue-penetrating element passable out of said catheter body in alateral direction so as to create an interstitial passageway through thewall of the luminal anatomical structure within which the catheter isinserted into a target anatomical location, said apparatus comprising:an emitting component which causes a signal to be emitted from saidtarget anatomical location; and, a receiving component which receivessaid signal from said anatomical location; one of said emitting andreceiving components being located at a fixed position relative to thepath which will be followed by said tissue penetrating element as saidtissue penetrating element passes out of said catheter, and beingthereby useable to position and orient said catheter such that saidtissue-penetrating element will create the desired interstitialpassageway into said target anatomical location.
 29. The system of claim28 wherein said emitting component and said receiving component are bothlocated on said passageway-forming catheter.
 30. The system of claim 28wherein one of said emitting component and said receiving component islocated at said target anatomical location, and the other thereof islocated on said passageway-forming catheter.
 31. The system of claim 28wherein said emitting component comprises an energy-emitting memberwhich emits a form of energy selected from the group of energy formsconsisting of: sonic energy; ultrasonic energy; light energy; laserlight energy; radio frequency energy; an electromagnetic signal; andwherein said receiving component comprises a sensor adapted to receivesaid form of energy.
 32. The system of claim 28 wherein said emittingand receiving components are respectively positioned such that, whensaid emitting and receiving components are brought into direct alignmentto direct alignment with one another, the passageway-forming catheterwill be properly positioned to cause said tissue-penetrating element topass from said passageway to forming catheter into said targetanatomical location, and wherein said system further comprises:apparatus for monitoring the intensity of the signal received by thereceiving component, such that one may determine when the signalreceived by the receiving component has been peaked, thereby indicatingthat the emitting and receiving components have been brought into directalignment with one another and the catheter is correctly positioned andoriented.
 33. The system of claim 32 wherein said apparatus formonitoring the intensity of the signal received by the receivingcomponent comprises in series: a signal conditioning and filteringcomponent; a rectifier; a leaky integrator; a analog to digitalconverter; and, a display adapted to display the strength of the signalreceived by the receiving component.
 34. The system of claim 28 whereinsaid emitting component comprises an elongate pliable wire having anemission-preventing shield formed laterally about the length of thewire, with the distal tip of the wire extending out of and beyond saidshield such that energy may be emitted by only the distal tip of thewire.
 35. The system of claim 28 adapted for use in a procedure whereinthe passageway-forming catheter is transluminally advanced into a firstblood vessel for the purpose of forming a passageway through the wall ofsaid first blood vessel and into said target anatomical location, andwherein one of said emitting and receiving components is insertable intosaid target anatomical location and the other thereof is mounted on saidpassageway-forming catheter.
 36. A system for forming an interstitialpassageway which extends through the wall of a luminal anatomicalstructure, said system comprising: a) a deflectable catheter having anelongate pliable catheter body, a distal end, at least one lumenextending longitudinally through the catheter body, and a distal endopening through which said lumen opens at the distal end of saidcatheter body, a portion of said catheter body immediately adjacent thedistal end thereof being alternately moveable between: i) a straightconfiguration; and, ii) a curved configuration; b) an imaging apparatuswhich is insertable through at least a portion of said at least onelumen of said deflectable catheter to provide an image of at least theluminal anatomical structure when said deflectable catheter is insertedinto said luminal anatomical structure; and, c) a tissue-penetratingelement which is advanceable through said at least one lumen of saidcatheter and out of said distal end opening such that, when the distalportion of the catheter is in its curved configuration within saidluminal anatomical structure, the tissue-penetrating element will passout of said distal end opening and through the wall of said luminalanatomical structure.
 37. The system of claim 36 wherein said catheterfurther comprises: a marker formed on said catheter at a first location,said marker being positioned at a known location on said catheter andbeing imagable by said imaging apparatus when said imaging apparatus isinserted into said at least one lumen of said catheter, said markerbeing thereby useable to facilitate selected rotation orientation ofsaid catheter within said luminal anatomical structure such that, whenthe distal portion of the catheter is moved to its curved configuration,the distal opening of the catheter will be aimed at a desired locationon said luminal anatomical structure.
 38. The system of claim 36 whereinsaid system further comprises: d) a passageway modifying apparatus whichis passable through said at least one lumen of said catheter and out ofsaid distal opening, said passageway modifying apparatus being useableto modify a passageway which has been initially formed by saidtissue-penetrating element.
 39. The system of claim 38 wherein saidpassageway modifying apparatus is selected from the group of passagewaymodifying apparatus consisting of: an apparatus for closing saidpassageway; an apparatus for stenting said passageway; an apparatus forenlarging said passageway; an apparatus for cauterizing said passageway;an apparatus for placing a channel connector within said passageway; anapparatus for blocking the lumen of an anatomized conduit on either sideof said passageway to effect flow through said passageway.
 40. Thecatheter of claim 9 wherein the marker is formed of material which isreflective of energy which is received by the imaging means for thepurpose of forming the image.
 41. The catheter of claim 9 wherein themarker is formed of material which is partially internally reflective ofenergy which is received by the imaging means for the purpose of formingthe image.
 42. The catheter of claim 9 wherein the marker is formed ofmaterial which is absorptive of energy which is received by the imagingmeans for the purpose of forming the image.